A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

• Status: Terminated
• Trial end date: 2014-01-20
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• Is 0 (at least 37 weeks gestation) to 17 years of age

• Is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated

• Is expected to receive ondansetron

• Female participants who have begun menstruating must have a negative pregnancy test

• Weighs ≥3.0 kg if <6 months of age, ≥6.0 kg if >6 months of age, and ≥7.5 kg if > 2 years of age

• Has a pre-existing venous catheter

Exclusion Criteria:

• Uses any illicit drugs or abuses alcohol

• Is pregnant or breast feeding

• Has a symptomatic central nervous system (CNS) tumor

• Has an infection or other uncontrolled disease other than cancer

• Has known history of heart QT wave prolongation